Diet Intervention in Food Sensitive Patients With IgA Nephropathy

NCT ID: NCT01203007

Last Updated: 2010-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to assess whether a tailored diet, eliminating antigens to which IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.

Detailed Description

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Conditions

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IGA Nephropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tailored diet

Tailored diet according to demonstrated food sensitivity

Group Type EXPERIMENTAL

Tailored diet

Intervention Type DIETARY_SUPPLEMENT

Tailored diet according to demonstrated food sensitivity, 6 months

Low-antigen content (LAC) diet

Low-antigen content diet

Group Type EXPERIMENTAL

Low antigen content diet

Intervention Type DIETARY_SUPPLEMENT

Low-antigen content diet for one month

Interventions

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Tailored diet

Tailored diet according to demonstrated food sensitivity, 6 months

Intervention Type DIETARY_SUPPLEMENT

Low antigen content diet

Low-antigen content diet for one month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Above 18 years
* IgA nephropathy (IgAN), verified by biopsy
* Proteinuria \> 1 g/24 h
* Having signed informed consent form

Exclusion Criteria

* Participation in another clinical trial
* Patients with celiac disease
* Introduction of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) during the last three months prior to inclusion
* Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Smerud Medical Research International AS

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University Hospital

Principal Investigators

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Hilde K Smerud, MScPharm

Role: STUDY_DIRECTOR

Uppsala University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Linköping University Hospital

Linköping, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Norway Sweden

Central Contacts

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Bengt Fellström, MD, PhD

Role: CONTACT

+46 18 611 4348

Hilde K Smerud, MScPharm

Role: CONTACT

+47 9011 6812

Facility Contacts

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Bengt Fellström, MD, PhD

Role: primary

+46 18 611 4348

Hilde K Smerud, MScPharm

Role: backup

+479011 6812

Other Identifiers

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SMR-2259

Identifier Type: -

Identifier Source: org_study_id